Evaluation of Myocardial Sympathetic Denervation in Parkinson's Disease Using [18F]FDOPA

Sponsor

Tel-Aviv Sourasky Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02495649

Collaborator

(none)

100

Enrollment

Location

Arm

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the added value of PET-CT with [18F]FDOPA tracer for Assessment of the Myocardial Sympathetic Denervation in patients with or suspected with Parkinson's disease.

The investigators expect to see normal values of uptake ratio of [18F]FDOPA , in patients with no synuclein underline pathology or previously known cardiovascular disease (no history of high blood pressure or take medications that influence the sympathetic system- exclusion criteria). Low values of uptake ratio is presumed to be found in patients diagnosed with Parkinson's disease or other synuclein pathology.

The expected normal ratio of Heart/liver uptake values will be determined from scans of patients refered to [18F]FDOPA scan and were found to have normal [18F]FDOPA scan of the basal ganglia and no cardiovascular diseases.

Condition or Disease	Intervention/Treatment	Phase
Parkinson	Other: [18F]-DOPA Device: PET-CT	N/A

Detailed Description

L-3,4-dihydroxy-6-[18F]fluoro-phenylalanine ([18F]FDOPA) might be a useful tracer for assessing myocardial sympathetic denervation in Parkinson's disease (PD) Patients. Compared to the routinely used I123 MIBG scan, [18F]FDOPA seems to have an advantage for the following reasons:

meta-iodobenzylguanidine (MIBG) is a false analog of norepinephrine while [18F]FDOPA is the radiolabelled form of DOPA, a direct precursor of dopamine which is subsequently converted to norepinephrine
123I MIBG, un-like norepinephrine, dose not undergo intracellular metabolism (19) while [18F]FDOPA undergo complex intracellular metabolism (17)
Studies have shown that I123 MIBG reuptake is almost exclusive by uptake mechanism 1. Uptake-2 mechanism of 123I-MIBG by the myocardium is not significant. Reuptake of norepinephrine (NE) in the synaptic cleft and is mainly by uptake 1 system but also in small amount by uptake 2 systems. The investigators assumption is that this double mechanism of reuptake will increase the concentration of [18F]FDOPA for better imaging

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Evaluation of Myocardial Sympathetic Denervation in Parkinson's Disease Using [18F]FDOPA

Actual Study Start Date :

Aug 1, 2015

Actual Primary Completion Date :

Sep 1, 2015

Anticipated Study Completion Date :

Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: [18F]-DOPA evaluate the added value of PET-CT with [18F]-DOPA tracer for Assessment of the Myocardial Sympathetic Denervation in patients with or suspected with Parkinson's disease.	Other: [18F]-DOPA To evaluate the feasibility of PET-CT with [18F]-DOPA to assess the myocardial sympathetic denervation in patients with or suspected with Parkinson's disease Device: PET-CT To evaluate the feasibility of PET-CT with [18F]-DOPA to assess the myocardial sympathetic denervation in patients with or suspected with Parkinson's disease

Arm

Intervention/Treatment

Other: [18F]-DOPA

evaluate the added value of PET-CT with [18F]-DOPA tracer for Assessment of the Myocardial Sympathetic Denervation in patients with or suspected with Parkinson's disease.

Other: [18F]-DOPA

To evaluate the feasibility of PET-CT with [18F]-DOPA to assess the myocardial sympathetic denervation in patients with or suspected with Parkinson's disease

Device: PET-CT

To evaluate the feasibility of PET-CT with [18F]-DOPA to assess the myocardial sympathetic denervation in patients with or suspected with Parkinson's disease

Outcome Measures

Primary Outcome Measures

The uptake of [18F]FDOPA will be measured by the ratio between the uptake in the heart and the uptake in the liver. [paitents will be scanned in PET- CT scaner for 10 minutes]
The uptake value of [18F]FDOPA will be measured by the ratio of standard uptake value (SUV) in the heart and the SUV in the liver. Normal uptake will be calculated by the mean uptake ratio in the healthy population (plus minus standard deviation) and used to compare to patients with abnormal [18F]FDOPA scan of the basal ganglia.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age ≥ 18
Signed Informed Consent
Patients referred for F-dopa scan of basal ganglia in the evaluation of Parkinson's disease or other extra pyramidal motor disorders.
Patients diagnosed with Parkinson's disease.

Exclusion Criteria:

Age < 18
Previous diagnosed Heart Disease.
History of High blood pressure.
On medications that influence the sympathetic system.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sourasky Medical Center	Tel-Aviv		Israel

Sponsors and Collaborators

Tel-Aviv Sourasky Medical Center

Investigators

Principal Investigator: Einat Even Sapir, Phd, MD, Tel-Aviv Sourasky Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

michal roll, Michal Roll PhD,MBA, DIRECTOR R&D devition, Tel-Aviv Sourasky Medical Center

ClinicalTrials.gov Identifier:

NCT02495649

Other Study ID Numbers:

TASMO-15-ES-0606-14-TLV-CTIL

First Posted:

Jul 13, 2015

Last Update Posted:

Jan 18, 2020

Last Verified:

Jan 1, 2020

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of Jan 18, 2020